Optimizing Dosing Regimen of Piperacillin/Tazobactam for Nosocomial Pneumonia

NCT01796717 | Unknown Phase 2 DMC

• 1 other identifier: CIH-WDH-201205001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

1. 1.To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia.
2. 2.To describe the pharmacokinetic profile of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) in patients with nosocomial pneumonia.
3. 3.To assess the safety profiles of piperacillin/tazobactam 4.5g q6h, prolonged or intermittent infusion in patients with nosocomial pneumonia.

Conditions

Nosocomial Pneumonia

Keywords

Piperacillin/tazobactam; MIC

Outcome Measures

Primary Outcomes (1)

• Extension of the Piperacillin / tazobactam infusion time effect evaluation

  To observe clinical and bacteriologic responses of different regimens of piperacillin/tazobactam (4.5g q6h, prolonged or intermittent infusion) for treatment of nosocomial pneumonia.

  2 weeks

Secondary Outcomes (1)

• Reducing antibiotic resistance

  2 weeks

Study Arms (2)

C Group

ACTIVE COMPARATOR

Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes

Drug: C Group

E Group

EXPERIMENTAL

Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours

Drug: E Group

Interventions

C Group DRUG

Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes

Also known as: nosocomial pneumonia, MIC

C Group

E Group DRUG

Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours

Also known as: nosocomial pneumonia, MIC

E Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged 18 to 70 years old.
• Inpatients with nosocomial pneumonia or bacteremia.
• i. Diagnosis of nosocomial pneumonia
• Chest radiographic infiltrate that is new or progressive.
• At least two or more of the following clinical findings suggesting infection.
• New onset of fever, oral temperature T\>38.3℃ or T\<36℃
• Purulent sputum
• WBC \> 12×10\^9/L or \<4×10\^9/L, or band form \>10%
• PaO2/FIO2\<240mmHg
• ii. Diagnosis of bacteremia: Positive blood culture and the isolated bacterial strain are considered to be infection cause.
• Patients are infected by piperacillin-tazobactam susceptible pathogen with MIC=4, 8 or 16mg/L.

You may not qualify if:

• The patients who received systematic antibacterial treatment more than 48 hours before enrollment and have clinical response.
• Severe pyemia with hypotension or/and evidences of failure of organic function (shock: systolic pressure \< 90mmHg or diastolic pressure \< 60mmHg, requiring more than 4 hours of administration of vasopressor(s)；renal impairment: urine volume \< 20 ml∕h or \< 80 ml∕4h after excluded any other potentials, acute renal failure need dialysis, CLcr\<40 mL/min).
• Documented infection caused by pathogens beyond the antibacterial spectrum of piperacillin/tazobactam.
• Previously diagnosed condition which tend to mimic or complicate the course and evaluation of the infectious process, e.g. bronchial obstruction, obstructive pneumonia, activate pulmonary malignancy, pulmonary abscess, empyema and active tuberculosis, which might interfere the course of the infectious disease and evaluation of the disease.
• History of allergy to penicillins.
• Pregnancy or breast-feeding women.
• Any conditions investigator considered might increase the risk of patients or interfere study results.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Pfizer: collaborator

Study Sites (2)

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

TianjinCIH

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Related Publications (3)

• Roberts JA, Kirkpatrick CM, Roberts MS, Dalley AJ, Lipman J. First-dose and steady-state population pharmacokinetics and pharmacodynamics of piperacillin by continuous or intermittent dosing in critically ill patients with sepsis. Int J Antimicrob Agents. 2010 Feb;35(2):156-63. doi: 10.1016/j.ijantimicag.2009.10.008. Epub 2009 Dec 16.

  PMID: 20018492 BACKGROUND

• Wang H, Chen M, Ni Y, Liu Y, Sun H, Yu Y, Yu X, Mei Y, Liu M, Sun Z, Chu Y, Hu Z, Huang X. Antimicrobial resistance among clinical isolates from the Chinese Meropenem Surveillance Study (CMSS), 2003-2008. Int J Antimicrob Agents. 2010 Mar;35(3):227-34. doi: 10.1016/j.ijantimicag.2009.11.010. Epub 2010 Jan 4.

  PMID: 20047820 BACKGROUND

• Lorente L, Jimenez A, Martin MM, Iribarren JL, Jimenez JJ, Mora ML. Clinical cure of ventilator-associated pneumonia treated with piperacillin/tazobactam administered by continuous or intermittent infusion. Int J Antimicrob Agents. 2009 May;33(5):464-8. doi: 10.1016/j.ijantimicag.2008.10.025. Epub 2009 Jan 15.

  PMID: 19150225 BACKGROUND

MeSH Terms

Conditions

Healthcare-Associated Pneumonia

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wang Donghao, Chief

  Tianjin Medical University Cancer Institute and Hospital

  STUDY CHAIR

Central Study Contacts

Wang Donghao, chief

CONTACT

022-23340123; donghaow@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: February 22, 2013
• Study Start: March 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 17, 2016

Record last verified: 2012-08

Locations

CN (2)